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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transferrin, Antigen, Antiserum, Control
510(k) Number K900875
Device Name RAICHEM(TM) SPIA(TM) TRANSFERRIN REAGENT
Applicant
Reagents Applications, Inc.
8225 Mercury Ct.
San Diego,  CA  92111
Applicant Contact GIOVANNI BUCOLO
Correspondent
Reagents Applications, Inc.
8225 Mercury Ct.
San Diego,  CA  92111
Correspondent Contact GIOVANNI BUCOLO
Regulation Number866.5880
Classification Product Code
DDG  
Date Received02/26/1990
Decision Date 03/06/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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